WARNING ABOUT LIFE-THREATENING INJURIES ASSOCIATED WITH SHOULDERFLEX MASSAGER

August 26, 2011

Here’s an important health alert for anyone who owns or uses a ShoulderFlex Massager distributed by King International in Beaver, Ore.

Do not use the ShoulderFlex Massager, shown below, because it can cause strangulation and death, as well as other serious injuries.

On August 25, the Food and Drug Administration (FDA) issued a safety alert to consumers who have purchased or use the ShoulderFlex Massager, businesses that sell the ShoulderFlex Massager, and health care professionals who recommend the ShoulderFlex Massager to their patients. Designed for home use, the ShoulderFlex Massager is a personal massage device intended to provide deep tissue massage to the neck, shoulder and back while the user lies on a flat surface. It consists of a massage unit that sits beneath the neck, a handheld controller, a memory foam pillow and a machine-washable sleeve. The device contains a rotating bar with removable massage “fingers” that may be adjusted by the user to customize the massage area and depth.

The Consumer Product Safety Commission has received reports of one death and one near-strangulation associated with the ShoulderFlex Massager. These incidents occurred when a necklace and clothing became caught in a piece of the device that rotates during use. The FDA is aware of two other reports of incidents involving clothing and hair becoming caught in the device.

The FDA has concluded that the ShoulderFlex Massager presents serious health risks, because hair, clothing and jewelry can become entangled in the massage device and cause serious injury or death. King International has distributed 11,934 devices since Oct. 18, 2003. The devices were sold at various stores and online retailers in the U.S.

Read the full FDA safety announcement.

What You Should Do

• Do NOT use the ShoulderFlex massager.
• Remove the power supply and massage fingers from the massager, then dispose all parts separately so that the massager cannot be reassembled and used.

Report any product quality problems to the FDA’s MedWatch program.